It's not uncommon for corporate executives to plead the Fifth in civil lawsuits when separate criminal charges are possible, nor does it indicate guilt, according to legal experts, but it certainly raises eyebrows.
Three top executives at Olympus invoked their constitutional right against self-incrimination in 2016 when asked about internal company emails tied to the company's role in scope-related superbug outbreaks.
"Olympus in Japan knew of the dangers of the duodenoscopes not being able to be adequately disinfected, even when Olympus guidelines are followed, yet they failed to notify healthcare providers in the U.S. of this problem," Rando Wick, a lawyer representing Seattle, WA-based Virginia Mason Medical Center in the case, told MD+DI at the time.
Lawyers representing Virginia Mason Medical Center and a patient's widow in a civil case against Olympus said the Tokyo executives declined to answer questions about the emails during two days of depositions in late 2016, at the U.S. Embassy in Tokyo, Kaiser Health News reported at the time.
Granted, as one legal expert told MD+DI, it is not uncommon for executives to plead the Fifth in these cases. Such situations can be complex, and there are "always facts beneath the surface of every case that the media and public doesn't see until we get to trial," said Mark Duval, president and CEO of Duval & Associates, a Minneapolis-based law firm that specializes in FDA regulations for products at all stages of the life cycle. "No defense lawyer would allow an executive to talk to the government without iron-clad immunity."
While Duval was not involved in or able to comment on the Olympus case, he added that anyone dealing with the prosecutorial arm of the government is "justifiably wary."
Still, the lesson to be learned here should be about how to address problems when they occur, not after the company has landed in hot water over it. Unfortunately, it seems Olympus has yet to learn that lesson.
In a recent warning letter to Olympus, FDA cited multiple violations including a failure to adequately establish and maintain procedures for implementing corrective and preventative action, including analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, etc.
According to the letter, Olympus has received about 160 complaints describing the distal end cover on its model MAJ-2315 endoscopes dropping out.
“Your firm performed trending and identified that number of complaints was above the expected numbers for that type of complaint. However, your firm did not consider this increasing trend of complaints to be a quality data input to initiate a corrective and preventive action," wrote Courtney Lias, director of the office of gastrorenal, obgyn, general hospital, and urology devices at FDA.